Therapeutic Effect of an Herbal Medicine on Anxiety

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Millet Roux.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Millet Roux
ClinicalTrials.gov Identifier:
NCT01178632
First received: August 8, 2010
Last updated: August 9, 2010
Last verified: August 2010
  Purpose

Phase III, double blind, randomized study, controlled by Valeriana officinalis L for evaluating the efficacy of association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. in generalized anxiety disorder. The treatment period will last four weeks and be followed by a post treatment visit.


Condition Intervention Phase
Anxiety Disorders
Drug: Passiflora
Drug: Valeriana officinalis
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Controlled, Phase III Study of an Herbal Medicine Association for Generalized Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by Millet Roux:

Primary Outcome Measures:
  • Hamilton anxiety scale score [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]
    The primary outcome measure for effectiveness will be the score of the Hamilton Anxiety Scale (HAM-A). This scale will be applied in the pre-treatment (baseline), in the two visits of the treatment and in the final visit (post-treatment). Tests will be done within groups, or between different assessments and baseline values, and intergroup comparisons, i.e. between the two treatment groups at each time.


Secondary Outcome Measures:
  • Insomnia gravity index [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]
    The secondary outcome measure for effectiveness will be the score of the Insomnia gravity index. This questionnaire will be applied in the pre-treatment (baseline), in the two visits of the treatment and in the final visit (post-treatment). Tests will be done within groups, or between different assessments and baseline values, and intergroup comparisons, i.e. between the two treatment groups at each time.

  • Clinical global impression rate scale and Patient global evaluation rate scale [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]
    The other secondary outcome measure for effectiveness will be the clinical global impression rate scale and patient global evaluation rate scale. These scales will be applied in the pre-treatment (baseline), in the two visits of the treatment and in the final visit (post-treatment). Tests will be done within groups, or between different assessments and baseline values, and intergroup comparisons, i.e. between the two treatment groups at each time.


Estimated Enrollment: 136
Study Start Date: October 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Passiflora, Anxiety Disorders
1 tablet Passiflora;Crataegus;Salix; PO;BID
Drug: Passiflora
01 tablet Passiflora p.o., b.i.d.
Other Name: PASSIFLORINE
Active Comparator: Valeriane, Anxiety Disorder
1 tablet Valeriana officinalis, PO, BID
Drug: Valeriana officinalis
Active Comparator group will receive 01 tablet of Valeriana officinalis, p.o., b.i.d.
Other Name: VALERIANE

Detailed Description:

The main objective of this study is to evaluate the clinical efficacy of the drug Passiflorine® (Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L) compared to Valeriana officinalis over a period of four weeks.

The improvement of anxiety disorders parameters (primary outcome) will be measured by the score of the Hamilton Anxiety Scale (HAM-A).

Does the administration of 2 tablets a day over a period of four weeks vs. Valeriana officinalis lead to an improvement in anxiety disorders?

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of generalized anxiety disorder
  • HAM-A scale > 17 and <30

Exclusion Criteria:

  • HAM-A scale > 30
  • Psychotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01178632

Contacts
Contact: MARIA ELISABETE A MORAES, MD, PhD 5585-32232903 betemora@matrix.com.br

Locations
Brazil
Clinical Pharmacology Unit - Unifac Not yet recruiting
Fortaleza, Ceara, Brazil, 60430-270
Principal Investigator: MARIA ELISABETE A MORAES, MD, PhD         
Sub-Investigator: ALEXANDRE AQUINO CAMARA, MD         
Sponsors and Collaborators
Millet Roux
Investigators
Study Director: MARIA ELISABETE A MORAES, MD, PhD CLINICAL PHARMACOLOGY UNIT - UNIFAC
  More Information

Additional Information:
No publications provided

Responsible Party: FRANCISCO ALVES BORGES, MILLET ROUX
ClinicalTrials.gov Identifier: NCT01178632     History of Changes
Other Study ID Numbers: MR4009
Study First Received: August 8, 2010
Last Updated: August 9, 2010
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Millet Roux:
Herbal
Phytotherapy
Passiflora
Valeriana
Anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014